Study of Cetuximab in Combination With Tarceva in Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00207077
First received: September 12, 2005
Last updated: April 7, 2011
Last verified: July 2008
  Purpose

The purpose of this study is to find a safe and effective dose of the combination of cetuximab (Erbitux) and Tarceva (erlotinib).


Condition Intervention Phase
Neoplasms
Drug: Cetuximab + Erlotinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Cetuximab in Combination With Erlotinib in Patients With Advanced Solid Malignancies

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety and efficacy of the combination of Tarceva and Erbitux

Secondary Outcome Measures:
  • Radiographic response

Estimated Enrollment: 33
Study Start Date: August 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Cetuximab + Erlotinib
IV solution + tablet, IV+ oral, ERB 100 mg/m2, 200 mg/m2, 250 mg/m2 IV + Erl 150 mg tablet, ERB weekly/ Erl once daily, Until disease progression.
Other Name: Erbitux

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Measurable disease
  • Life expectancy of at least 3 months
  • Must have at least one prior chemotherapy containing a platinum

Exclusion Criteria:

  • Known or documented brain metastases
  • Prior cetuximab therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207077

Locations
United States, Delaware
Christiana Care Health Services, Inc.
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00207077     History of Changes
Other Study ID Numbers: CA225-101
Study First Received: September 12, 2005
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Advanced Solid Tumors

Additional relevant MeSH terms:
Erlotinib
Cetuximab
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014